Drugs@FDA: FDA-Approved Drugs
Company: WATSON LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LAMOTRIGINE | LAMOTRIGINE | 2MG | TABLET, FOR SUSPENSION;ORAL | Prescription | AB | No | No |
LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | AB | No | No |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/22/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/30/2020 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
01/30/2020 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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09/26/2014 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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05/18/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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09/29/2011 | SUPPL-6 | Labeling-Package Insert, REMS-Proposal, Labeling-Medication Guide |
Label is not available on this site. |
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09/21/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
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09/21/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |
LAMOTRIGINE
TABLET, FOR SUSPENSION;ORAL; 2MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LAMICTAL CD | LAMOTRIGINE | 2MG | TABLET, FOR SUSPENSION;ORAL | Prescription | Yes | AB | 020764 | GLAXOSMITHKLINE LLC |
LAMOTRIGINE | LAMOTRIGINE | 2MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 076928 | WATSON LABS |
TABLET, FOR SUSPENSION;ORAL; 5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LAMICTAL CD | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | Yes | AB | 020764 | GLAXOSMITHKLINE LLC |
LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 201168 | ALEMBIC |
LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 090401 | AUROBINDO PHARMA |
LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 076701 | DR REDDYS LABS LTD |
LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 079099 | GLENMARK PHARMS LTD |
LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 079204 | TARO |
LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 076928 | WATSON LABS |
LAMOTRIGINE | LAMOTRIGINE | 5MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 078009 | ZYDUS PHARMS USA INC |
TABLET, FOR SUSPENSION;ORAL; 25MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
LAMICTAL CD | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | Yes | AB | 020764 | GLAXOSMITHKLINE LLC |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 201168 | ALEMBIC |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 090401 | AUROBINDO PHARMA |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 076701 | DR REDDYS LABS LTD |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 079099 | GLENMARK PHARMS LTD |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 079204 | TARO |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 076928 | WATSON LABS |
LAMOTRIGINE | LAMOTRIGINE | 25MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 078009 | ZYDUS PHARMS USA INC |